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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIDEAL IMPLANT Structured Breast Implant
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantBimini Health Tech
420 Stevens Ave.
Suite 220
Solana Beach, CA 92075
PMA NumberP120011
Supplement NumberS022
Date Received05/27/2021
Decision Date10/27/2021
Product Code FWM 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00858052
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
Approval OrderApproval Order
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